Safety and efficacy of IDEA-070 for the treatment of pain and inflammation induced by photodynamic therapy of actinic keratosis

INTERVENTION: Product Name: IDEA‐070 Product Code: IDEA‐070/41 Pharmaceutical Form: Cutaneous suspension INN or Proposed INN: Ketoprofenum CAS Number: 22071‐15‐4 Current Sponsor code: IDEA‐070/41 Concentration unit: % percent Concentration type: equal Concentration number: 2.4‐ Pharmaceutical form of the placebo: Cutaneous suspension Route of administration of the placebo: Cutaneous use CONDITION: Patients suffering from actinic keratosis to be treated with PDT PRIMARY OUTCOME: Main Objective: Effect of IDEA‐070 compared to placebo on pain and inflammation induced by PDT Primary end point(s): Endpoints related to and including the primary efficacy endpoints are:; ‐Patient evaluation of pain using a 100 mm VAS, rated 3.0‐3.5 h before PDT, immediately after PDT, 4 h after PDT (day 1), 24 h after PDT (day 2), on day 4, day 8, and day 28 ; ‐Investigator evaluation of inflammation using an aggregate (sum) score and corresponding subscores, evaluated 3.0‐3.5 h before PDT, 4 h after PDT (day 1), 24 h after PDT (day 2), on day 4, day 8, and day 28 ; ‐The change of pain VAS from 3.0‐3.5 hours prior to PDT, i.e. the difference “assessment value” – “3.0‐3.5 hours prior to PDT”; primary efficacy endpoint for “assessment value” = “immediately post PDT until 24 h post PDT”; ‐The change of aggregate (sum) score of inflammation from 3.0‐3.5 hours prior to PDT, i.e. the difference “assessment value” – “3.0‐3.5 hours prior to PDT”; primary efficacy endpoint for “assessment value” = “4 h post PDT until day 8”; Secondary Objective: Clearance rate; Safety of IDEA‐070 INCLUSION CRITERIA: Diagnosis of actinic keratosis to be treated with PDT ‐ affecting equal sized areas of both sides of the head ‐ affecting at least 10% of the area of photo‐exposure Aged 18‐85 years Reliable method of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intraueterine‐devices, sexual abstinence or vasectomised partner) Willing to obstain from excessive sun/UV exposure during the course of the study Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range